Clinical TrialsFirst in research means best in care

“ Melbourne Health aspires to its vision of First in Care, Research and Learning and fostering our role in world class clinical trials is critical to achieving this vision. We have a long and proud history in research, driven by the involvement of our key opinion leaders and dedicated research staff. Through our desire to improve the health of our community, we hope that the proportion of our patients enrolled in clinical trials at the Royal Melbourne will only increase in the years ahead, and that we continue to build upon our impressive research portfolio.”

Dr Gareth Goodier, Chief Executive, Melbourne Health

“ On any given day, enrolment in a clinical trial may be the optimal treatment for our patients, and therefore it is imperative that we continue to build our research footprint. Clinical trials are not supplementary or an adjunct to patient care – they are patient care. At the Royal Melbourne, clinical research is deeply embedded in our organisational culture and we aspire to further develop our relationships with our industry partners.”

Professor Ingrid Winship, Executive Director of Research, Melbourne Health

The Royal Melbourne Hospital Clinical Trials

The Royal Melbourne Hospital, NorthWestern Mental Health and the Doherty Institute are part of Melbourne Health

“ The growth of personalised medicine means it’s an exciting time to be involved in clinical trials. For patients, participation enables carefully monitored clinical care with access to treatment at the leading edge of current developments. For investigators, clinical trial participation provides first-hand experience of emerging therapies and the opportunity to inform the dialogue about the place of new treatments in clinical practice.”

Professor Jo Douglass – Clinical Immunology and Allergy

“ We have an outstanding track record in conducting clinical trials in epilepsy, stroke, multiple sclerosis, Alzheimer’s disease and movement disorders, with a reputation as a national and international leader. These continue to be an area of strength for which we typically recruit well, and we also have an interest in many of the more niche neurology indications.”

Professor Terence O’Brien – Neurology

“ Improved outcomes for patients with some types of blood cancers are due to the development of new drugs and we have been very active in this area. A great example is our involvement in the first trials of a brand new drug, venetoclax, which shows tremendous potential for treatment of patients with chronic lymphocytic leukaemia, the findings of which were published in the New England Journal of Medicine.”

Professor Andrew Roberts – Clinical Haematology and Bone Marrow Transplant Unit

Clinical trials facilitation serviceThe Royal Melbourne Hospital (RMH) has a central point of contact for all general sponsor enquiries, including feasibility approaches for new studies. This sponsor liaison provides an intermediary and oversight function during study start-up to ensure efficient site activation and resolution of any issues.

Contact the Clinical Research Manager, Richard.Verrelli@mh.org.au or +61 3 9342 7348.

Fast approvals for ethics and governance submissionsThe Office for Research continues to lead the way in improving ethics and governance processes thus ensuring that all submissions are approved quickly and with proficiency, operating within the guidelines of the National Health and Medical Research Council (NHMRC).

Leading the way

84%of valid ethics submissions approved in under 30 days

87%of valid governance submissions approved in under 5 days

50%of total governance submissions approved within 1 day

The Royal Melbourne Hospital has an integrated and progressive research office which facilitates a culture of clinical trial research. Our focus is on working with researchers and sponsors to drive prompt site activation and the achievement of participant accrual targets.

“ We strive for excellence in our care for every patient, but evidence-based and standard treatments remain imperfect. Through integrating research, clinical trials and state-of-the-art clinical medicine, we can obtain access to newer advanced therapies and innovative treatments whilst providing exceptional care. Partnering with our patients in this way allows us to achieve the best outcomes.”

Associate Professor Kathy Nicholls and Professor Stephen Holt – Nephrology

Streamlined study start-upThe RMH is proud to have been selected by the NHMRC to participate in the Good Practice Process, which aims to streamline the site assessment and authorisation of clinical trials.

As part of this initiative, the RMH has implemented efficiencies to optimise study start-up and remove roadblocks. In addition, the RMH is also collaborating with 11 partner organisations to streamline and harmonise ethical and governance review for all multi-centre human health research.

Standard feesThe costs associated with conducting a clinical trial at the RMH are competitive and in accordance with the principles of fair market value. A fee schedule is used across the organisation to ensure increased transparency and consistency between research departments. This helps to significantly improve budget negotiation timelines to ensure quicker site activation.

High quality and audit readinessOur policies ensure that investigators are equipped to lead and manage clinical trial studies. It is standard practice at the RMH that study investigators must hold current TransCelerate-accredited ICH-GCP certification before issuing governance approval to commence a study.

In addition to external audits organised by sponsors, internal auditing is also conducted regularly at the RMH. Studies and departments are randomly chosen to be assessed, ensuring audit readiness at all times.

A focus on strong recruitmentAchieving participant enrolment in line with targeted accrual is taken very seriously. The RMH’s extensive patient catchment and considerable referral networks allow recruitment projections to be met and often exceeded. Clinical trial enrolment is recorded in an internal patient management database which is analysed by the Office for Research to ensure that the RMH is meeting its recruitment targets.

LARGE RECRUITMENT POOL (WITHIN A 12-MONTH PERIOD):

173,516 outpatient appointments

86,926inpatients discharged

33 random internal audits conducted in 2015

Phase 1 expertiseIn addition to phase 2 and 3, phase 1 clinical trials are a major focus of our business and an increasing proportion of studies now fall in this category. Plans are underway for a dedicated phase 1 unit to be established within the hospital. A number of first-time-in-human studies have been conducted at the hospital, and on several occasions the RMH enrolled the first patient globally.

Key opinion leadersThe RMH has a significant number of world-renowned key opinion leaders across a range of therapeutic areas who are in high demand by study sponsors. These physicians work at the very forefront of medical advances and are highly research-active, often with more than a decade of clinical trial experience and countless publications to their name.

Dedicated clinical trials research unit Facilities for clinical trials exist within all departments of the RMH. Redevelopment work is currently underway for a dedicated clinical trials research unit within the city campus to open in late 2016. This brand new space will be custom built to meet all the demands of conducting commercially sponsored trials.

In addition, the Victorian Comprehensive Cancer Centre (VCCC) links to the RMH by an air-bridge and will include 24 phase 1 beds for cancer clinical trials. The VCCC is a facility which will accommodate 83% of all patients enrolled into cancer clinical trials in Victoria.

147 commercially sponsored studies have been approved in the last 2 years

“ The Dermatology department at the Royal Melbourne is involved with inflammatory skin diseases and autoimmune diseases. We have conducted numerous clinical trials in these areas – especially psoriasis, eczema and pemphigus. Our team consists of a dedicated team of 12 consultant dermatologists, two research fellows and specialised research nurses. With a large cohort of patients across a vast catchment area, we have the capacity to recruit strongly.”

Professor George Varigos – Dermatology

2271 IN THE LAST TWO YEARS THE RMH COLLABORATED WITH

global sponsor partners

contract research organisation partners

“ Our department runs a large inpatient and outpatient service for people with diabetes and our clinical trial portfolio includes new treatments and interventions; diabetes complications; and trials which focus on type 1 diabetes prediction and prevention. Trial recruitment is aided by the Biogrid database which captures clinical data on all patients attending our clinics.”

Professor Peter Colman – Diabetes and Endocrinology

“ The Dermatology department at the Royal Melbourne is involved with inflammatory skin diseases and autoimmune diseases. We have conducted numerous clinical trials in these areas – especially psoriasis, eczema and pemphigus. Our team consists of a dedicated team of 12 consultant dermatologists, two research fellows and specialised research nurses. With a large cohort of patients across a vast catchment area, we have the capacity to recruit strongly.”

Professor George Varigos – Dermatology

“ Clinical trial research enhances the care and wellbeing of our patients. Across our scope of patient services – including influenza, HIV, hepatitis, RSV and staphylococcus – we have the capacity to recruit many patients through clinical trial research. In addition, the variance of Australia’s flu season to that of the Northern Hemisphere places us in a strategic position to complement seasonally dependent trials.”

Professor Joe Sasadeusz – Victorian Infectious Diseases Service

“ Clinical Trials Medicine is good medicine. Patients participating in clinical trials are carefully looked after and receive considerable attention. Participants feel they are being given additional treatment options and, with a degree of altruism, many embrace the opportunity to enrol on trials testing novel therapies.”

Professor Mark Rosenthal – Parkville Cancer Clinical Trials Unit

research NEUROLOGY

NEPHROLOGY

INFECTIOUS DISEASES

HAEMATOLOGY & BONE MARROWTRANSPLANT

INTENSIVE CARE

DIABETES & ENDOCRINOLOGY

DERMATOLOGY

IMMUNOLOGY & ALLERGY

COLORECTAL MEDICINE

HEPATOLOGY

MENTAL HEALTH

CARDIOLOGY

RESPIRATORY MEDICINE UROLOGY

OPHTHALMOLOGY

SURGERYGASTROENTEROLOGY

Melbourne Health300 Grattan StreetParkville VIC 3050

AustraliaT: +61 3 9342 8530F: +61 3 9342 8548

E: research@mh.org.auwww.thermh.org.au

ABN: 73 802 706 972